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Study · Non-randomized trial · n = 155 · 2017

8 results

Efficacy and safety of a 3-month dosing regimen of degarelix in Japanese patients with prostate cancer: a phase II maintenance-dose-finding study.

Ozono S, Tsukamoto T, Naito S, Ohashi Y, Ueda T, Nishiyama T, Maeda H, Kusuoka H, Akazawa R, Ito M, Akaza H

Japanese journal of clinical oncology1 May 2017Cited by 7 (Europe PMC)

PMID28334771 (opens in a new tab)PMCIDPMC5421626 (opens in a new tab)DOI10.1093/jjco/hyx011 (opens in a new tab)PepBankPUB-28334771
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In Japanese prostate cancer patients, cumulative probability of testosterone ≤0.5 ng/ml during Days 28-364 was 88.3% with 360 mg maintenance degarelix.

    In plain wordsIn Japanese prostate cancer patients, 360 mg maintenance degarelix gave an 88.3% cumulative probability of testosterone ≤0.5 ng/ml.

    Peptide
    Degarelix
    Outcome
    Not applicableCumulative castration probability
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    240 mg initial, 360 mg every 84 days · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Cumulative probability
    88.3%
    360 mg
    95% CI
    77.9 to 94%
    360 mg

    Source sentences

    Summary
    The cumulative probability of serum testosterone ≤0.5 ng/ml (Days 28-364) was 88.3% (95% confidence interval: 77.9-94.0%) and 97.2% (95% confidence interval: 89.4-99.3%) in the 360 and 480 mg groups, respectively.
    1 context sentence
    Summary · context
    In this Phase II, open-label, parallel-group study, 155 Japanese prostate cancer patients were randomized to treatment with degarelix administered subcutaneously at a maintenance dose of 360 or 480 mg every 84 days for 12 months, after receiving an initial dose of 240 mg.
  2. 02HumanNon-randomized trialEfficacy outcome

    In Japanese prostate cancer patients, cumulative probability of testosterone ≤0.5 ng/ml during Days 28-364 was 97.2% with 480 mg maintenance degarelix.

    In plain wordsIn Japanese prostate cancer patients, 480 mg maintenance degarelix gave a 97.2% cumulative probability of testosterone ≤0.5 ng/ml.

    Peptide
    Degarelix
    Outcome
    Not applicableCumulative castration probability
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    240 mg initial, 480 mg every 84 days · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Cumulative probability
    97.2%
    480 mg
    95% CI
    89.4 to 99.3%
    480 mg

    Source sentences

    Summary
    The cumulative probability of serum testosterone ≤0.5 ng/ml (Days 28-364) was 88.3% (95% confidence interval: 77.9-94.0%) and 97.2% (95% confidence interval: 89.4-99.3%) in the 360 and 480 mg groups, respectively.
    1 context sentence
    Summary · context
    In this Phase II, open-label, parallel-group study, 155 Japanese prostate cancer patients were randomized to treatment with degarelix administered subcutaneously at a maintenance dose of 360 or 480 mg every 84 days for 12 months, after receiving an initial dose of 240 mg.
  3. 03HumanNon-randomized trialEfficacy outcome

    In Japanese prostate cancer patients, median PSA changed by -95.05% at Day 364 with 360 mg maintenance degarelix.

    In plain wordsIn Japanese prostate cancer patients, PSA fell by a median 95.05% from baseline with 360 mg maintenance degarelix.

    Peptide
    Degarelix
    Outcome
    DecreasePSA change
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    240 mg initial, 360 mg every 84 days · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Median percent change in serum PSA
    −95.05%
    360 mg group, baseline to Day 364

    Source sentences

    Summary
    The median percent change in serum prostate-specific antigen level from baseline to Day 364 was -95.05% and -96.43% in the 360 and 480 mg groups, respectively; the proportion of patients with prostate-specific antigen failure was 2.7% and 1.3%.
    1 context sentence
    Summary · context
    In this Phase II, open-label, parallel-group study, 155 Japanese prostate cancer patients were randomized to treatment with degarelix administered subcutaneously at a maintenance dose of 360 or 480 mg every 84 days for 12 months, after receiving an initial dose of 240 mg.
  4. 04HumanNon-randomized trialEfficacy outcome

    In Japanese prostate cancer patients, median PSA changed by -96.43% at Day 364 with 480 mg maintenance degarelix.

    In plain wordsIn Japanese prostate cancer patients, PSA fell by a median 96.43% from baseline with 480 mg maintenance degarelix.

    Peptide
    Degarelix
    Outcome
    DecreasePSA change
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    240 mg initial, 480 mg every 84 days · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Median percent change in serum PSA
    −96.43%
    480 mg group, baseline to Day 364

    Source sentences

    Summary
    The median percent change in serum prostate-specific antigen level from baseline to Day 364 was -95.05% and -96.43% in the 360 and 480 mg groups, respectively; the proportion of patients with prostate-specific antigen failure was 2.7% and 1.3%.
    1 context sentence
    Summary · context
    In this Phase II, open-label, parallel-group study, 155 Japanese prostate cancer patients were randomized to treatment with degarelix administered subcutaneously at a maintenance dose of 360 or 480 mg every 84 days for 12 months, after receiving an initial dose of 240 mg.
  5. 05HumanNon-randomized trialEfficacy outcome

    In Japanese prostate cancer patients, PSA failure at Day 364 occurred in 2.7% with 360 mg maintenance degarelix.

    In plain wordsIn Japanese prostate cancer patients, PSA failure occurred in 2.7% with 360 mg maintenance degarelix.

    Peptide
    Degarelix
    Outcome
    Not applicablePSA failure
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    240 mg initial, 360 mg every 84 days · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Proportion with PSA failure
    2.7%
    360 mg group, Day 364

    Source sentences

    Summary
    The median percent change in serum prostate-specific antigen level from baseline to Day 364 was -95.05% and -96.43% in the 360 and 480 mg groups, respectively; the proportion of patients with prostate-specific antigen failure was 2.7% and 1.3%.
    1 context sentence
    Summary · context
    In this Phase II, open-label, parallel-group study, 155 Japanese prostate cancer patients were randomized to treatment with degarelix administered subcutaneously at a maintenance dose of 360 or 480 mg every 84 days for 12 months, after receiving an initial dose of 240 mg.
  6. 06HumanNon-randomized trialEfficacy outcome

    In Japanese prostate cancer patients, PSA failure at Day 364 occurred in 1.3% with 480 mg maintenance degarelix.

    In plain wordsIn Japanese prostate cancer patients, PSA failure occurred in 1.3% with 480 mg maintenance degarelix.

    Peptide
    Degarelix
    Outcome
    Not applicablePSA failure
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    240 mg initial, 480 mg every 84 days · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Proportion with PSA failure
    1.3%
    480 mg group, Day 364

    Source sentences

    Summary
    The median percent change in serum prostate-specific antigen level from baseline to Day 364 was -95.05% and -96.43% in the 360 and 480 mg groups, respectively; the proportion of patients with prostate-specific antigen failure was 2.7% and 1.3%.
    1 context sentence
    Summary · context
    In this Phase II, open-label, parallel-group study, 155 Japanese prostate cancer patients were randomized to treatment with degarelix administered subcutaneously at a maintenance dose of 360 or 480 mg every 84 days for 12 months, after receiving an initial dose of 240 mg.
  7. 07HumanNon-randomized trialSafety outcome

    In Japanese prostate cancer patients receiving degarelix, injection-site reaction was the most frequent adverse event.

    In plain wordsIn Japanese prostate cancer patients receiving degarelix, injection-site reaction was the most frequent adverse event.

    Peptide
    Degarelix
    Outcome
    Not applicableInjection-site reactions
    Study

    n = 155

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated · subcutaneous · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    The most frequent adverse event was injection site reaction; however, this did not cause any patient to discontinue treatment.
    1 context sentence
    Summary · context
    In this Phase II, open-label, parallel-group study, 155 Japanese prostate cancer patients were randomized to treatment with degarelix administered subcutaneously at a maintenance dose of 360 or 480 mg every 84 days for 12 months, after receiving an initial dose of 240 mg.
  8. 08HumanNon-randomized trialSafety outcome

    In Japanese prostate cancer patients receiving degarelix, injection-site reactions caused no treatment discontinuations.

    In plain wordsIn Japanese prostate cancer patients receiving degarelix, injection-site reactions caused no treatment discontinuations.

    Peptide
    Degarelix
    Outcome
    Not applicableDiscontinuation from injection-site reaction
    Study

    n = 155

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    The most frequent adverse event was injection site reaction; however, this did not cause any patient to discontinue treatment.
    1 context sentence
    Summary · context
    In this Phase II, open-label, parallel-group study, 155 Japanese prostate cancer patients were randomized to treatment with degarelix administered subcutaneously at a maintenance dose of 360 or 480 mg every 84 days for 12 months, after receiving an initial dose of 240 mg.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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